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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Study Status Completed
Application Number P980040 S058/ PAS001
Date Current Protocol Accepted 03/03/2017
Study Name ECR IOL PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of this post-approval study is to evaluate the rates of severe visual distortions for the TECNIS Toric IOLs

with Extended Cylinder Range of approximately 3.00 D to 4.75 D of cylinder correction at the corneal plane (Models

ZCT450, ZCT525 and ZCT600) in clinical practice and to ensure the continued safety of the approved devices.

Study Design: Prospective, multicenter, bilateral, non-randomized, open-label clinical new enrollment study.

Study Population Description Bilateral cataracts with corneal astigmatism of approximately 2.00 D to 4.75 D (with 3.00 D to 4.75 D in at least one eye) based on the combination of preoperative keratometirc cylinder and the expected effect of surgicallyinduced astigmatism (SIA).There is no control group.
Sample Size Up to 120 subjects will be enrolled to achieve bilateral implantation in approximately 80 subjects; a minimum of 15 subjects will be implanted with a TECNIS Toric ZCT600 in at least one eye, and the remaining subjects will be implanted with either a TECNIS Toric ZCT450, ZCT525 or ZCT600 in at least one eye. With 80 subjects and a severe visual distortion rate of 0.025, this study has 86% probability of achieving a half-width of 0.05 for a 95% confidence interval for the rate of severe visual distortions.

Subjects will be enrolled at up to 20 sites in the United States. Each site should implant a minimum of 6 subjects, and no site may enroll more than 20% of the enrollment total.

Data Collection Study Endpoints

Primary Endpoint

The primary endpoint is the rate of severe visual distortions based on data collected from a self-administered Patient

Reported Visual Distortion Questionnaire (PRVDQ).

The rate of severe visual distortions is defined as the percentage of subjects who report a severe visual distortion under overall circumstances at 6 months postoperative for any of the following 5 visual distortion items of interest:

lines that slant, tilt, split or separate

flat surfaces appearing curved

objects appearing further away or closer than they actually are objects appearing to have a different size or shape

physical discomfort related to vision

Distortions will be assessed using the overall circumstance reply at the 6-month visit. The frequency and proportion of subjects reporting one or more of these items as severe will be used to determine the rate of severe visual distortions.

Secondary Endpoints

Ratings of individual items included in the visual distortion questionnaire (PRVDQ)

Mean percent reduction in absolute cylinder

Mean refractive cylinder, mean refractive cylinder compared to intended, mean spherical equivalent and mean spherical equivalent compared to intended

Percent of eyes with absolute cylinder within 0.50 D and within 1.00 D of intended

Percent of eyes with spherical equivalent within 0.50 D and within 1.00 D of intended

Uncorrected distance visual acuity (monocular and binocular)

Best corrected distance visual acuity (monocular and binocular)

Rates of medical and/or lens findings

Rates of IOL repositioning procedures (secondary surgical intervention) due to IOL misalignment

Mean difference between IOL axis marker location and postoperative steep keratometry meridian

Rates of other adverse events

Follow-up Visits and Length of Follow-up 6 months total follow up
Interim or Final Data Summary
Actual Number of Patients Enrolled 118 (101 patients implanted)
Actual Number of Sites Enrolled 20
Patient Follow-up Rate Overall follow-up rate among those enrolled: 86% (101/118)

The follow-up rate among those implanted was 100% (101/101).
Final Safety Findings Of the 100 subjects completing the PRVDQ questionnaire at 6 months, none reported severe visual distortions under overall circumstances for any of the five items of interest.

A small number of subjects reported severe symptoms on questions in the PRVDQ questionnaire, pertaining to other visual symptoms.

Lens findings of misalignment were the most common finding reported by the investigator, for a total of 18 eyes.

A total of 15 subjects experienced 17 ocular serious/device-related adverse events (SAE/ADEs) in 17 eyes as determined by the investigators. Sixteen events were categorized as serious by medical monitor(s) based on the definition of SAE per the protocol. These included 12 reports (a rate of 11.9%) of IOL misalignment that required secondary surgical intervention to reposition the lens.

One had an IOL exchange due to residual astigmatism and myopia from the initial IOL. One incidence of iridocyclitis was reported but was not considered serious nor device-related and resolved without sequelae. One report of cystoid macular edema was reported but has also resolved without sequelae.
Final Effect Findings The refractive endpoint outcomes and visual acuity results do not raise any concerns because the refractive endpoint outcomes included satisfactory effectiveness results. However, I will defer Dr. Hilmantel, clinical reviewer, for his clinical assessment.
Study Strengths & Weaknesses Strength: 100% follow-up rate, there is a comparator group.

Weaknesses: Small sample size (100), no randomization, lack of representativeness (94% were White).
Recommendations for Labeling Changes The PAS study design, methods and results must be included in the labeling.

¿ Additionally, it should be included the following:

Demographic distribution results.

o Protocol deviations reported during the study: 118 enrolled patients 76 deviations


o Numbers and rates of secondary surgical interventions to correct misalignments for the

lenses with the high corneal astigmatism under investigation. Rates should be reported

both “per eye” and “per subjects”.

o A full description of the distributions of residual refractive cylinder and “residual

cylinder – target cylinder.” These should include the following percentiles: 0th, 5th,

10th, 25th, 50th, 75th, 90th, 95th, and 100th percentiles.

o Secondary surgical interventions occur at a substantially higher rate for subjects

receiving implants for TECNIS® Toric IOL models with higher cylinder powers than for

those receiving lower cylinder models; and

o Patients requiring implants for TECNIS® Toric IOL models with higher cylinder powers

are likely to have greater residual astigmatism and poorer uncorrected visual acuities

than those requiring lower cylinder models. Those requiring high cylinder models are

more likely to need spectacle correction at distance for some tasks.

o A full description of the distribution of monocular uncorrected visual acuities, including

the proportions of eyes with logMAR acuity worse than 0.3, 0.2, and 0.1. They should

also provide the following percentiles for monocular uncorrected acuities: 0th, 5th,

10th, 25th, 50th, 75th, 90th, 95th, and 100th percentiles.

ECR IOL PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 01/29/2016 01/29/2016 On Time
one year report 07/30/2016 07/28/2016 On Time
18 month report 01/28/2017 01/23/2017 On Time
two year report 07/30/2017 09/07/2017 Overdue/Received
three year report 07/30/2018 07/26/2018 On Time
four year report/final report 07/30/2019 08/01/2019 Overdue/Received

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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